EDrug Molecules &Pharmaceutical Intermediates &Small Molecule Pro-drug

Drug Molecules &Pharmaceutical Intermediates &Small Molecule Pro-drug

We have state-of-the-art GMP facilities that offer multi-step, end-to-end continuous processing. Our extensive drug substance manufacturing capabilities are further enhanced, allowing us to advance your project from early development and optimization through to scale-up and commercial production. We provide manufacturing support at laboratory, kilogram, and pilot scales for all stages from preclinical research to clinical trials, supplying quantities ranging from milligrams to kilograms, while continuously improving chemical processes. We are also well-equipped to support your commercial manufacturing needs, including product launch and market supply, with capacities ranging from kilograms to over 100 metric tons. See Further information for more about our drug molecules & pharmaceutical intermediates & small molecule pro-drug

Services

Design of efficient, environmentally friendly, and economic synthesis routes
Optimization of intermediate synthesis steps to enhance the yield of target products
Strict control of intermediate purity and impurities to ensure the quality of the final product
Rapid delivery of preclinical samples at mg-g scale
Process transfer, development, and scale-up production (non-GMP &GMP), with kg-scale GMP sample delivery
Preparation of impurity reference standards
Analytical method development, validation, product testing,and stability studies
Establishment of quality standards
Process optimization to improve yield or product quality

Technical Advantages

Introduction, design and research of pharmaceutical intermediates
Screening of commercialization routs for technology
Development and optimization of commercial processes through design of experiments (DoE) and quality by design (QbD)
Study of unit operation and confirmation of key process parameters at each step
Research on impurity structure, origin, and control.
Definition of GMP starting materials
Repaid achievements of small-scale results for pharmaceutical intermediates, taking on pilot-scale tasks to provide reliable process data for industrial production
Capability for structural analysis and performance testing of pharmaceutical intermediates.